The following data is part of a premarket notification filed by Cordis Corporation with the FDA for Rain Sheath Transradial.
| Device ID | K181592 |
| 510k Number | K181592 |
| Device Name: | RAIN Sheath Transradial |
| Classification | Introducer, Catheter |
| Applicant | Cordis Corporation 1820 McCarthy Boulevard Milpitas, CA 95035 |
| Contact | Ankita Phophalia |
| Correspondent | Ankita Phophalia Cordis Corporation 1820 McCarthy Boulevard Milpitas, CA 95035 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-18 |
| Decision Date | 2018-08-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705032079041 | K181592 | 000 |
| 20705032082164 | K181592 | 000 |
| 20705032082171 | K181592 | 000 |
| 20705032082188 | K181592 | 000 |
| 20705032082195 | K181592 | 000 |
| 20705032082201 | K181592 | 000 |
| 20705032082218 | K181592 | 000 |
| 20705032082225 | K181592 | 000 |
| 20705032082232 | K181592 | 000 |
| 20705032082157 | K181592 | 000 |
| 20705032082140 | K181592 | 000 |
| 20705032082065 | K181592 | 000 |
| 20705032082072 | K181592 | 000 |
| 20705032082089 | K181592 | 000 |
| 20705032082096 | K181592 | 000 |
| 20705032082102 | K181592 | 000 |
| 20705032082119 | K181592 | 000 |
| 20705032082126 | K181592 | 000 |
| 20705032082133 | K181592 | 000 |
| 20705032082249 | K181592 | 000 |
| 20705032082256 | K181592 | 000 |
| 20705032078969 | K181592 | 000 |
| 20705032078976 | K181592 | 000 |
| 20705032078983 | K181592 | 000 |
| 20705032078990 | K181592 | 000 |
| 20705032079003 | K181592 | 000 |
| 20705032079010 | K181592 | 000 |
| 20705032079027 | K181592 | 000 |
| 20705032079034 | K181592 | 000 |
| 20705032078952 | K181592 | 000 |
| 20705032078945 | K181592 | 000 |
| 20705032082263 | K181592 | 000 |
| 20705032082270 | K181592 | 000 |
| 20705032082287 | K181592 | 000 |
| 20705032078891 | K181592 | 000 |
| 20705032078907 | K181592 | 000 |
| 20705032078914 | K181592 | 000 |
| 20705032078921 | K181592 | 000 |
| 20705032078938 | K181592 | 000 |
| 20705032082058 | K181592 | 000 |